Author, as appears in the article.: Ferry JM; Galera-Martínez R; Campoy C; Sáenz de Pipaón M; Jarocka-Cyrta E; Walkowiak J; Romańczuk B; Escribano J; Gispert M; Grattarola P; Gruszfeld D; Iglesia I; Grote V; Demmelmair H; Handel U; Gallier S; Koletzko B
Department: Medicina i Cirurgia
URV's Author/s: Escribano Subías, Joaquín / Gispert Llauradó, Mariona
Keywords: Party diagnostic-criteria Nutrition & Paediatric dermatology Immunology Eczema Dietetics validation severity scorad index questionnaire prevalence paediatric dermatology nutrition & dietetics life immunology growth clinical-trials allocation
Abstract: INTRODUCTION: Atopic dermatitis (AD) is a chronic, inflammatory skin condition significantly affecting quality of life. A small randomised trial showed an approximately one-third lower incidence of AD in goat milk formula-fed compared with cow milk formula-fed infants. However, due to limited statistical power, AD incidence difference was not found to be significant. This study aims to explore a potential risk reduction of AD by feeding a formula based on whole goat milk (as a source of protein and fat) compared with a formula based on cow milk proteins and vegetable oils. METHODS AND ANALYSIS: This two-arm (1:1 allocation), parallel, randomised, double-blind, controlled nutritional trial shall enrol up to 2296 healthy term-born infants until 3 months of age, if parents choose to start formula feeding. Ten study centres in Spain and Poland are participating. Randomised infants receive investigational infant and follow-on formulas either based on whole goat milk or on cow milk until the age of 12 months. The goat milk formula has a whey:casein ratio of 20:80 and about 50% of the lipids are milk fat from whole goat milk, whereas the cow milk formula, used as control, has a whey:casein ratio of 60:40 and 100% of the lipids are from vegetable oils. The energy and nutrient levels in both goat and cow milk formulas are the same. The primary endpoint is the cumulative incidence of AD until the age of 12 months diagnosed by study personnel based on the UK Working Party Diagnostic Criteria. The secondary endpoints include reported AD diagnosis, measures of AD, blood and stool markers, child growth, sleep, nutrition and quality of life. Participating children are followed until the age of 5 years. ETHICS AND DISSEMINATION: Ethical approval was obtained from the ethical committees of all participating institutions. TRIAL REGISTRATION NUMBER: NCT04599946.
Thematic Areas: Saúde coletiva Psicología Odontología Nutrição Medicine, general & internal Medicine (miscellaneous) Medicine (all) Medicina veterinaria Medicina iii Medicina ii Medicina i Interdisciplinar General medicine Farmacia Ensino Enfermagem Educação física Ciências biológicas iii Ciências biológicas ii Ciências biológicas i Ciências ambientais Ciência da computação Biotecnología
licence for use: https://creativecommons.org/licenses/by/3.0/es/
Author's mail: mariona.gispert@urv.cat joaquin.escribano@urv.cat
Author identifier: 0000-0002-5041-459X
Record's date: 2024-08-03
Papper version: info:eu-repo/semantics/publishedVersion
Link to the original source: https://bmjopen.bmj.com/content/13/4/e070533.long
Licence document URL: https://repositori.urv.cat/ca/proteccio-de-dades/
Papper original source: Bmj Open. 13 (4): e070533-
APA: Ferry JM; Galera-Martínez R; Campoy C; Sáenz de Pipaón M; Jarocka-Cyrta E; Walkowiak J; Romańczuk B; Escribano J; Gispert M; Grattarola P; Gruszfeld D (2023). Effects of infant feeding with goat milk formula or cow milk formula on atopic dermatitis: protocol of the randomised controlled Goat Infant Formula Feeding and Eczema (GIraFFE) trial. Bmj Open, 13(4), e070533-. DOI: 10.1136/bmjopen-2022-070533
Article's DOI: 10.1136/bmjopen-2022-070533
Entity: Universitat Rovira i Virgili
Journal publication year: 2023
Publication Type: Journal Publications
Repositori URV